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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

New: Take the RAC Exam Online

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

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As hospitals as well as state and commercial labs have now ramped up their testing for the novel coronavirus to almost 100,000 tests per day, many observers, including the US Food and Drug Administration (FDA) are looking back at the last two months wondering what took so long to get to this point.
A front-page article in Sunday’s New York Times explained how the virus spread for weeks without any testing, with experts pointing to early problems with the CDC’s first...

As the number of COVID-19 cases increase in the US and hospitals struggle with keeping their doctors and nurses protected, the Food and Drug Administration (FDA) on Monday released guidance explaining how it will relax certain regulatory requirements to increase the production and availability of certain personal protective equipment (PPE) such as gowns and gloves.
As early as late February, FDA began warning of PPE shortages, and hospitals in areas hit hard by the c...

Opening the door to the wider use of unapproved but potential COVID-19 treatments, the US Food and Drug Administration (FDA) late Sunday issued an emergency use authorization (EUA) to allow the US Biomedical Advanced Research and Development Authority (BARDA) to distribute donated hydroxychloroquine sulfate and chloroquine phosphate products to doctors, who can decide whether to prescribe them to hospitalized teen and adult patients with COVID-19 when a clinical trial is n...

With an eye on drug supply disruptions, the US Food and Drug Administration (FDA) on Friday published new guidance on how manufacturers should notify FDA of permanent halts or interruptions to manufacturing certain products that are likely to lead to a meaningful disruption in supply.
An FDA spokesman told Focus that so far, only one firm is reporting a shortage of one human drug. FDA previously declined to name the firm or the drug, citing confidential commercial i...

The European Medicines Agency’s Committee for Advanced Therapies on Friday announced that it has recommended a conditional authorization for Novartis’ gene therapy Zolgensma (onasemnogene abeparvovec) as a treatment for babies and young children with spinal muscular atrophy (SMA), a rare and often fatal genetic disease.
EMA’s recommendation is based on the preliminary results of one completed clinical trial and three supporting studies in patients with SMA with differ...

As there are still no approved treatments for COVID-19, the US Food and Drug Administration (FDA) this week warned Ireland-based Carahealth for offering unapproved herbal products and other products referred to as “Immune Tonic” on its website to mitigate, prevent, treat, diagnose or cure COVID-19.
The warning letter, released publicly on Friday, follows the distribution of warning letters to seven companies for making fraudulent and unsupported claims about products,...

The US Food and Drug Administration (FDA) on Thursday officially ended a fledgling pilot program that was part of an effort to provide more transparency on the drug approval process. The agency said it’s working on a new approach to disclosing study reports.
Last June, the agency was already pushing away from the clinical study report (CSR) pilot because of lackluster participation (FDA noted that Janssen was the only sponsor that agreed to participate) and said it wo...

As part of work to facilitate a faster and less expensive conformity assessment procedure for those marketing certain medical devices, the European Commission earlier this week adopted revised harmonized standards.
The commission's implementing decisions relate to the medical devices, in vitro diagnostics and active implantable medical devices directives. The revised standards are meant to speed the production of medical face masks, gloves, containers for intravenous in...

A wide-ranging $2 trillion coronavirus emergency relief bill is expected to become law tomorrow and included in it are provisions not only related to drug and medical device shortages and COVID-19 testing, but also a new user fee system for over-the-counter (OTC) drugs.
Overall, the bill is meant to provide relief to the struggling economy and to help government agencies and health facilities as more than 70,000 in the US now have COVID-19 and as the rate of new infecti...

The European Medicines Agency (EMA) on Wednesday released for consultation a new draft guideline on points that clinical trial sponsors should consider on the implications of the coronavirus disease (COVID-19) on methodological aspects of ongoing trials.
While noting that “it is not possible to give general applicable advice on how the different aspects related to the pandemic should be handled, as implications on clinical trials are expected to be manifold,” the EMA’s...

In a reversal, Gilead said Wednesday that it submitted a request to the US Food and Drug Administration (FDA) to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the treatment of COVID-19.
Earlier in March, Gilead was granted the designation because the potential antiviral would help to treat COVID-19, which currently affects fewer than 200,000 patients in the US. If the company had kept the designation and remdesivir w...

As COVID-19 continues to disrupt Europe and pull medical device companies in different directions, Stella Kyriakides, European Commissioner for Health and Food Safety, said Wednesday that the commission will propose to delay the implementation of the Medical Devices Regulation (MDR) by one year. MDR was due to apply from 26 May.
If approved, the delay will come as a relief to device manufacturers. MedTech Europe on Monday called on the commission to pause the date ...